User:Shawndouglas/sandbox/sublevel2

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The intention of this document is 1. to assist labs searching for a laboratory informatics product with identifying their system needs and 2. to help labs better determine if a specific vendor/product meets their requirements in the form of a request for information (RFI). The idea is to allow users to incorporate a standardized specifications sheet in their comparison of various laboratory informatics products.

This questionnaire lists the extensive requirements of an electronic laboratory notebook (ELN). It attempts to be comprehensive and includes many items that do not apply to every lab. Additionally, some laboratories' requirements include a functionality item not common to other labs. The last section, 1.5 "Custom functions," is designed for the vendor to insert any additional functionality that doesn't fall under the categories provided.

When referencing a particular item for someone else, use the section number followed by the requirement letter, e.g. 1.4.2.a for "The system architecture is modular or extensible and can easily and efficiently be modified to facilitate the addition of new functionality as business needs change."

Requirement code and notes

In responding to each requirement, the vendor must select a requirement code from the following:

• Y: Meets requirement in commercial off-the-shelf solution as delivered/configured (or vendor provides service)
• YC: Meets requirement only with customization (additional code, using a third-party application, etc.)
• N: Does not meet requirement
• I: Informational response only, N/A

The vendor should ideally enter a requirement code and a response for each functionality question.

Printing or saving

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Note: Tables are currently not being rendered in PDFs as we like through the MediaWiki Collection extension. While we sure would love for you to make a PDF of this document, be warned: the tables don't format as intended, using either the "Create a book" or "Download as PDF" processes. For now you're best off selecting "Printable version" and printing that instead.

1.0 Vendor information

1.0 Vendor information Company name Physical address Website LIMSwiki web page Contact name and title Contact e-mail Contact phone and fax Years in business

1.1 Vendor services

1.1 Vendor services Request for information Requirement code Vendor response a. The vendor offers an online and/or on-site demonstration. b. The vendor provides a detailed project plan that includes the project team, timeline, deliverables, and risk and issue management procedures. c. The vendor explains their overall project approach, deliverables, time constraints, and any other criteria for the project. d. The vendor provides reliable cost estimates and pricing schedules, including all products and services in the scope of work. e. The vendor details the amount of time and staff that the purchaser will have to provide for the implementation process. f. The vendor can explain the maintenance and support offered during and after implementation, including times and methods of availability, issue escalation and management, etc. g. The vendor provides a support schedule for the implementation process, including optional support levels, their function, and availability. h. The vendor provides support during the "go-live" period between system validation/operational deployment and final acceptance/beginning of maintenance and support agreements. i. The vendor provides a gap analysis after initial system installation, identifying the deliverables or tasks remaining. j. The vendor provides a table linking each deliverable to the corresponding user requirement specification it fulfills. k. The vendor uses a consistent training methodology for educating new users. l. The vendor supplies ELN-specific training program curricula. m. The vendor provides user, administrator, developer, installation, and reference manuals. n. The vendor provides design qualification documentation. o. The vendor provides installation qualification documentation. p. The vendor provides operation qualification documentation. q. The vendor provides performance qualification documentation during implementation. r. The vendor provides well-documented system upgrades that authorized users can independently install. s. The vendor provides source code for the system. t. The vendor provides an optional comprehensive set of test codes suitable for use by the purchaser.

1.2 Information technology

1.2.1 General IT 1.2.1 General IT Request for information Requirement code Vendor response a. The system operates with a traditional client-server architecture, with software installed on each machine that needs to access the system. b. The system operates with a web-based interface, hosted on a server and accessed via a web browser on most any machine. c. The system contains a single, centralized database that supports multiple sites and departments. d. The system's database conforms to the Open Database Connectivity Standard (ODBC). e. The system is designed so upgrades to the back-end database do not require extensive reconfiguration or effectively cripple the system. f. The system is designed to not be impacted by multiple users or failover processes. g. The system applies security features to all system files. h. The system applies log-in security to all servers and workstations accessing it. i. The system provides a workstation and server authentication mechanism. j. The system applies Secured Socket Layer (SSL) encryption on the web client interface. k. The system encrypts client passwords in a database, with support for multi-case and special characters. l. The system uses TCP/IP as its network transport. m. The system allows automated backup and restore capability without support intervention, as well as manual backups. n. The system maintains the transactional history of system administrators. 1.2.2 Hardware environment 1.2.2 Hardware environment Request for information Requirement code Vendor response a. The system proves compatible with a variety of hardware environments. b. The system can be utilized with a touch-screen. 1.2.3 Software environment 1.2.3 Software environment Request for information Requirement code Vendor response a. The system proves compatible with a variety of software environments. b. The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server.

1.3 Regulatory compliance and security

1.3.1 Regulatory compliance 1.3.1 Regulatory compliance Request for information Requirement code Vendor response a. The system supports 21 CFR Part 11 requirements, including log-in security, settable automatic logouts, periodic requirements for mandatory password changes, limits on reusability of passwords, and full electronic signature. b. The system supports the requirements of 37 CFR rules like 1.671, 41.152, and 41.207. c. The system supports the requirements of Federal Rules of Evidence (FRE) like Rule 803 and 901. d. The system supports HIPAA requirements. e. The system supports GALP and/or GAMP standards. f. The system meets government requirements for handling classified information and documents. g. The system maintains date- and time-stamped audit trails of all data manipulation — such as changes to results, data analysis parameters, and methods — as consistent with all applicable regulations and standards, making the information available for review, copying, and reporting to authorized users. h. The system audit log retains all data, prohibits any deletions, and allows user comments. i. The system provides additional persistent auditing capabilities, such as the audit of cancelled tests and scheduled system functions. j. The system provides the ability to both automatically and manually add secure electronic signature to documents and other data. k. The system uses public key infrastructure (PKI) and a third-party time stamping authority (TSA) for its digital signatures. l. The system provides the option of a double signature scheme for the purpose of patent protection. m. The system keeps all data and its format intact and captures modifications of that data as a version, including date and time of those modifications, for regulatory purposes. n. The system can automatically validate and approve data prior to being moved to the main database. 1.3.2 Security 1.3.2 Security Request for information Requirement code Vendor response a. The system allows administrators and other authorized users to configure multiple levels of user rights and security by site location, department, group, role, and/or specific function. b. The system allows administrators and users to reset user passwords. c. The system features and enforces adjustable rules concerning password complexity, reuse, and expiration. d. The system can lock a user out after a specified number of consecutive failed log-in attempts. e. The system provides the option for automatic user logout based on keyboard or mouse inactivity. f. The system makes authority checks to ensure only authorized individuals can use the system to perform an operation. g. The system allows authorized users to modify records, while also maintaining an audit trail of such actions. h. The system allows authorized users to manually delete records, while also maintaining an audit trail of such actions. i. The system prompts users to declare a reason for making changes to or deleting data in the system. j. The system allows authorized users to generate a detailed user access record. k. The system provides email notification of lockout, security access, and improper workstation access. l. The system provides a mechanism to allow a user read-only access to stored data. m. The system allows automatic and/or manual holds or locks to be placed on data to ensure it goes unaltered or remains retrievable during a retention period. n. The system can first feed data from connected non-CFR-compliant instruments through a virtual environment that is compliant (audit trailed, secure, versioned, etc.) before being stored. o. The system can control whether users are able to export data to portable long-term storage media like a USB flash drive or recordable DVD. p. The system employs automatic file encryption on stored data. q. The system employs checks to enforce permitted sequencing of steps and events.

1.4 General system functions

1.4.1 General functions 1.4.1 General functions Request for information Requirement code Vendor response a. The system offers non-ELN trained personnel the ability to easily access system data via an intuitive, user-friendly Windows-type graphical user interface (GUI) which permits the display of stored data. b. The system allows authorized users to configure their GUI to a specific language, character set, and time zone. c. The system permits remote access for users, system admins, and support agents? d. The system allows for the use of navigation keys to freely move from field to field. e. The system allows data tables to be sorted. f. The system can send on-screen output to a printer or file without contradicting view-only statuses. g. The system supports multiple users and instruments entering data simultaneously, without disruption. h. The system contains one or more spell-check dictionaries that allow authorized users to add, edit, or remove entries. i. The system integrates chemical drawing and computational tools. j. The system includes a synthesis sheet parser and generator. k. The system allows the import of chemical structure and spectroscopic files? l. The system provides full metadata, keyword, and field search capability, including the use of multiple search criteria. m. The system allows for advanced queries of molecular patterns and properties, like those associated with the SMARTS language. n. The system permits users to query by functional group or designed structure. o. The system allows users to build, save, and edit queries for future use. p. The system includes the ability to search and import from multiple databases, including those containing legacy data. q. The system provides data archival and retention functionality for both paper-based and electronic laboratory records, effectively maintaining the archives as technology changes. r. The system allows bookmarking of pages, images, experiments, and other content. s. The system notifies users of events like the scheduling and completion of tasks. t. The system includes the ability to set up alerts via email. u. The system supports scheduling of tasks like analysis requests, instrument maintenance, and group meetings. v. The system has real-time messaging capabilities for experiment and project collaborators. w. The system supports the use of a voice recognition system (for navigation or transcription) or has that functionality. x. The system offers integrated or online user help screens. 1.4.2 Configuration and customization 1.4.2 Configuration and customization Request for information Requirement code Vendor response a. The system architecture is modular or extensible and can easily and efficiently be modified to facilitate the addition of new functionality as business needs change. b. The system has an application programming interface (API) or a similar software development toolkit (SDK). If web-based, the API should support Simple Object Access Protocol (SOAP), representational state transfer (REST), or both. c. The system supports customized screens with user-definable information specific to a customer, department, analysis, etc. d. The system allows a user to independently add fields without requiring reconfiguration of the system, even after routine upgrades and maintenance. e. The system permits users to create personal and sharable experiment templates. f. The system allows for the integration of additional printers and scanners both locally and externally. 1.4.3 Pre-experiment 1.4.3 Receiving and scheduling Request for information Requirement code Vendor response a. The system supports barcoded sample labeling and tracking. b. The system provides compound and batch registration. c. The system provides extensive project and experiment management tools to create, manage, and run single-step, multi-step, and other types of experiments. d. The system provides tools for making advanced chemical calculations, including stoichiometric, titration, and reaction yield calculations. e. The system allows editing of biological sequences at the molecular level. f. The system allows the creation of searchable image annotations. 1.4.4 Post-experiment 1.4.4 Analysis and data entry Request for information Requirement code Vendor response a. The system can manage and store both sample- and non-sample-related data, including images from microscopes, GCMS scans of peaks, PDF files, spreadsheets, or even raw data files from instrument runs for later processing. b. The system can manage and store media objects like digital photos, bitmaps, movies, and audio files. c. The system can link objects to other objects, e.g. linking a specification to an experimental result or linking files between projects. d. The system provides a searchable repository for user notebooks present and past. e. The system can process text-to-structure conversions automatically. f. The system allows users to comment on experiment results, observations, and conjectures as well as allow for linking to and from comments. g. The system allows users to create project Gantt charts. h. The system captures and stores an encrypted PDF (or other document format) of a completed page. i. The system captures and stores images from image analysis. j. The system can process automated uploading of field-derived sample data. k. The system permits manual data entry of experiment results and other data. l. The system allows automated or semi-automated data insertion. m. The system stores non-narrative textual results in searchable fields. n. The system can graphically display the results of one or more experiments in a graph (normalized or otherwise) for the purpose of visualizing data or searching for possible trends. o. The system stores test-related analysis comments with the experiment. p. The system provides auto-commenting for common laboratory result comments. q. The system provides for high-volume multi-component transfers of test results, with the ability to automatically match samples to experiments in either a backlog mode or a designated file mode, to parse the data, and to review and commit the sample data. r. The system validates/approves sample data prior to being moved to the main database. s. The system's results validation process accesses all information about a sample or group of samples, including comments or special information about the sample. t. The system uses a menu-driven process for results validation. u. The system can clearly differentiate released preliminary data from fully validated results. v. The system can manage QA/QC test results. w. The system allows manual entry of QA/QC data not captured as part of the system's regular processes. 1.4.6 Instruments 1.4.6 Instruments Request for information Requirement code Vendor response a. The system bilaterally interfaces with instruments and related software based on the Unix and Windows platforms. b. The system can download data directly from laboratory instruments. c. The system allows file transfer of data from instruments via intelligent interfaces or multi-sample/multi-test ASCII files, with full on-screen review prior to database commitment. d. The system can track and report on the usage of attached laboratory instruments. e. The system can automatically (or manually allow an authorized user to) remove an instrument from potential use when it falls out of tolerance limit or requires scheduled calibration. f. The system maintains a reportable database of preventative maintenance, calibration, and repair records for attached laboratory instruments. g. The system can schedule calibration, verification, and maintenance tasks on attached instruments and make that schedule available for viewing. h. The system allows users to create and edit instrument maintenance profiles. 1.4.7 External system interfaces 1.4.7 External system interfaces Request for information Requirement code Vendor response a. The system supports a library of common electronic data deliverable (EDD) formats. b. The system can transfer data to and from other record management systems. c. The system integrates with Microsoft Exchange services. d. The system can import data from and export data to Microsoft Word, Excel, Access, and/or Powerpoint. e. The system can interface with non-Microsoft programs. f. The system can interface with enterprise resource planning (ERP) systems. g. The system can interface with internal and external laboratory systems like laboratory information management systems (LIMS) and electronic laboratory notebooks (ELNs). h. The system can leverage the application programming interface (API) of other systems to establish integration between systems. i. The system can interface with third-party chemical drawing tools like ChemDraw, MarvinSketch, and Ketcher. j. The system can interface with chemistry databases, compound management systems, and substance logistics systems. k. The system provides a real-time interface for viewing live and stored data transactions and errors generated by interfaced instruments and systems. l. The system supports dockable mobile devices and handles information exchange between them and the system. m. The system supports the use of optical character recognition (OCR) software. 1.4.8 Reporting 1.4.8 Reporting Request for information Requirement code Vendor response a. The system includes a versatile report writer and forms generator that can generate reports from any data in the system. b. The system can interface with a third-party reporting application. c. The system includes a custom graphic generator for forms. d. The system allows the development of custom templates for different types of reports. e. The system maintains template versions and renditions, allowing management and tracking of the template over time. f. The system can generate template letters for semi-annual reports. g. The system uses Microsoft Office tools for formatting reports. h. The system automatically generates experiment reports at specified points in the experimental process. i. The system provides multiple ways to visualize data in reports, including graphs, trend bars, pie charts, spectrum, etc. for the purpose of presenting information and identifying trends. j. The system makes graphic and tabular data vector-scalable in reports. k. The system allows for internal hyperlinking to source data in reports. l. The system can indicate whether a report is preliminary, amended, corrected, or final while retaining revision history. m. The system can automatically generate laboratory reports of findings and other written documents. n. The system can automatically generate and transmit exception reports for all stored out-of-specification data. o. The system provides an ad-hoc web reporting interface to report on user-selected criteria. p. The system can automatically generate and post periodic static summary reports on an internal web server. q. The system can transmit reports in a variety of ways including fax, e-mail, print, and website in formats like RTF, PDF, HTML, XML, DOC, XLS, and TXT. r. The system supports PDF/A, an ISO-standardized version of the Portable Document Format (PDF). s. The system includes a rules engine to determine the recipients of reports and other documents based on definable parameters. 1.4.9 Laboratory management 1.4.9 Laboratory management Request for information Requirement code Vendor response a. The system provides laboratory management tools to connect one or more labs, departments, or groups for the purpose of bettering collaborations. b. The system allows for the management of documents like SOPs, MSDS, etc. to better ensure they are current and traceable. c. The system manages and reports on reference samples, reagents, and other inventory, including by department. d. The system automatically warns specified users when inventory counts reach a definable threshold and either prompt for or process a reorder. e. The system allows authorized users to monitor and report on reference and reagent creation, use, and expiration.

1.5 Custom requirements

1.7 Custom requirements Request for information Requirement code Vendor response a. b. c. d. e. f. g. h. i. h. i. j.